Quality Manager Pharma

il y a 1 jour

Lyon e, France FED Ingénierie Temps plein

**Le cabinet de recrutement FED Ingénierie, spécialisé sur l'ensemble des métiers techniques et industriels, recherche pour son client spécialisé dans la pharmaceutique : Un Quality Manager Pharma (H/F) en CDI situé à Lyon Poste à pourvoir immédiatement - 45-55k selon profil**
**Votre fonction**:
QA/QC duties:

- Responsible to release products based on a documentation verification, in compliance with applicable regulations and relevant quality standards;
- Ensures continuous qualification of existing products and supports development of new portfolios; ensures data management and its validity (respect of data integrity rules)
- Validates manufacturer’s certificates of analysis (CoA) and creates CoA’s for customers; as well as other certificates (CoO etc.)
- Collaborates with external laboratories for sample analysis if applicable/ if needed
- Handles complaints related to product quality; oversees distribution service complaints and provides support if needed
- Enforces regulatory compliance within the organization with Pharmaceutical Intermediate & Specialty Chemicals (PI SC) focus
- Responds to internal colleagues for any type of technical product-related questions (per BU)
- Participates in organization and preparation of customer Quality Audits
- Participates in organization and preparation of Internal Audits of

QMS:

- Engages with European Quality Team (ability to work in a matrix organization)
- Works on continuous improvement of the existing processes
- Contributes to processes and procedures creations
- Monitors validity of existing Actylis and Suppliers certificates (GMP/ GDP/ ISO/ etc.) (maintenance of Supplier Qualifications)
- Executes work in line with the established internal rules and Standard Operating Procedures (SOP) and applicable norms
- Monitors changes in product related regulations (BU)
- Executes assigned training (QMS)

**Votre profil**:

- Scientific background in Biology, Chemistry, Biochemistry or Biotechnology
- At least 5 years (5-10) relevant experience in working with Quality Management Systems, Quality Assurance / Quality Control
- Product Stewardship experience (regulatory support, REACH regulation knowledge etc.)
- Knowledge of API GMP guidelines and practices, ISO 9001:2015 are required.
- Fluent English required, German is a significant plus.

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